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Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000

DISCONTINUATION OR NO DISCONTIUNATION: COMPARISON OF SINGLE UNIT HIV ANTIGEN TESTING VS. POOLED NAT TESTING. Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000. OBJECTIVE. To develop more sensitive HIV antigen assays

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Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000

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  1. DISCONTINUATION OR NO DISCONTIUNATION:COMPARISON OF SINGLE UNIT HIV ANTIGEN TESTING VS. POOLED NAT TESTING Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000

  2. OBJECTIVE To develop more sensitive HIV antigen assays Short term: Comparable sensitivity to pooled NAT testing Long term: Sensitivity equivalent to single unit NAT testing

  3. SENSITIVITY OF RESEARCH PRISM HIV Ag VS. CURRENT HIV ANTIGEN ASSAY ASSAY p24 ANTIGEN Estimated RNA Copies/ml @ Dilution of pg/ml (est.) copies/ml 1:96 1:1200 4 4 Research PrismHIV Ag 1-2 1x10 -2x10 104-208 8-16 HIVAG-1MC 7-10 7x10 4 -1x10 5 729-1041 58-83 1 pg = 1x104 copies/ml

  4. Comparison Between Sensitive HIV Antigen Testing and NAT • Sensitivity of antigen assay is ~1.0 pg or ~10,000 • copies of viral RNA • Even at a claimed 50 copies/ml sensitivity for NAT: • - a sample must have at least 4800 copies of • viral RNA/ml to be detected in a pool of 96, or • - 60,000 copies of viral RNA/ml in a pool of 1200

  5. EARLY SEROCONVERSION SAMPLES: COMPARISON OF POOLED NAT VS. HIV ANTIGEN TESTING PANEL/BLEED # ABBOTT Research NAT (copies/ml)a Copies/ml @ Dilution of HIVAG-1MCa PRISM AGc Roche NGI bDNA 1:96 1:1200 S/COb S/CO SV-0251/D 0.34 3.05 16000 167 13 SV-0321/A 0.46 3.08 20000 208 17 PRB-941/3 0.55 2.32 50000 521 42 PRB-943/3 0.72 2.35 100000 1042 83 PRB-945/3 0.72 1.96 90000 20000 938/208 75/17 BCP-9013/6 0.47 1.98 56350 587 47 BCP-6240/7 0.53 1.98 11690 122 10 BCP-9016/9 0.72 2.06 69010 719 58 a Data obtained from panel information sheets b S/CO > 1.00 is reactive c Research data

  6. Advantages of Individual HIV Antigen Testing vs Pooled NAT Testing • Fully automated system for antigen testing • Rapid test results • Process controls for enhanced GMP compliance • No sample preparation/contamination issues • Ability to confirm using neutralization test • Simplicity for implementation • No pools to dilute sensitivity • No dissection of pools • No shipping of specimens

  7. CONCLUSIONS • Gap between individual antigen testing • using a sensitive assay for HIV antigen • and NAT of pooled samples may not be significant • As opposed to discontinuation: • Manufacturers should be encouraged to develop ultra-sensitive HIV antigen assays with sensitivities equal to or greater than single unit NAT

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